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Novel Method for Assessing Risk of Breast Cancer Metastasis

SK1557

Summary of Invention

A genome-wide analysis to characterize the methylomes of breast cancers identified a link between breast cancer methylomes and metastatic potential. Further, MSKCC investigators determined the methylome signatures in specific subsets of breast cancers and developed a clinical test that can predict the aggressiveness of a tumor and the risk of metastasis in a breast cancer patient. This set of genes can be assayed using either PCR or mass spectrometry. The test utilizes tumor DNA (either paraffin-embedded or frozen) from the patient and involves relatively simple, clinically practicable methods. Assessing the methylome of a tumor can help direct physicians towards more aggressive therapy for patients likely to develop metastasis while sparing patients at low risk for metastasis from unnecessary measures. The marker sets are particularly applicable to methods and kits for use in connection with human breast cancer, colon cancer, and glioma.

Background

Instructions encoded by DNA and carried out by the cell are dictated both by DNA sequence information and by epigenetic (non-base pair) changes to the DNA. These epigenetic changes to DNA include methylation of specific bases. Cancer-specific alterations in DNA methylation are hallmarks of human malignancies. However, the nature of the breast cancer epigenome and its effects on metastatic behavior remained obscure. Dr. Timothy A. Chan and his colleagues have now shown that the methylome of breast cancer establishes a foundation for assessing the risk of metastasis.

Advantages

This method:

utilizes patient DNA rather than RNA, as is the case with the current leading biomarker panel;

serves as an accurate predictor of survival in conjunction with known biomarkers; and

can be used in patients with early-stage breast cancer.

Market Need

An estimated 207,000 breast cancer cases were diagnosed during 2010 alone. In roughly 60% of breast cancer diagnoses, cancer is confined to the primary site, and, in about 33%, cancer has spread no further than the regional lymph nodes. Therefore there is a clear need for a relatively simple prognostic test that assesses metastatic potential in the approximately 192,500 breast cancer patients diagnosed annually with locoregional disease. Current mRNA-based expression analysis methods have significant limitations, and there is a need in the market for more accurate prognostic tools.